US FDA: industry considers GDUFA III facility correspondence proposals
The US FDA says the industry is considering proposals to accelerate generic drug approvals discussed during the 4th round of discussions about GDUFA III.
The agency shared details last week, explaining the talks focused on “proposals to advance earlier approvals of generic applications.” It added, “industry will inform FDA of its position with the proposals in the coming weeks.”
Discussion of GDUFA III – a law designed to speed access to generics and reduce costs to industry that is due to be reauthorized – began on October 1st when the industry and the agency focused on pre-submission of facility correspondence, transportation and communication.
Talks since then have sought to thrash out the specifics. One of the sticking points – according to minutes from a meeting on October 15 – is how facility information provided by drug firms and CDMOs will be used by the FDA.
According to minutes released at the time, “Considerable time was spent on the pre-submission facility correspondence program to ensure FDA and Industry gained a better understanding of the current program, how the information submitted enables FDA to make a determination of whether or not an inspection is needed, and which information is most critical and Industry’s challenges with meeting these needs.”
The most recent discussion took place on October 29.
US FDA finalises cleanliness guidelines for compounders
The US FDA has published guidelines to help drug compounding facilities ensure their facilities are clean.
“This guidance describes examples of insanitary conditions that FDA has observed. This guidance specifically addresses drugs, including biological products, produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or repackage biological products.”
The coronavirus pandemic has reduced M&As in the biopharma space according to research in Nature. The study suggests firms are spending less on takeovers designed to expand their drug candidate pipelines.
The US list of essential drugs published last month is primarily focused on drugs used in acute care according to analysis by the Pink Sheet.
Reuters reports the Sputnik V is 92% effective at protecting people from COVID-19 according to interim trial results.
Interim analysis of Pfizer and Biontech’s vaccine that was also released this week indicate the product is 90% effective.
The Business Standard reports Strides Pharma is building a vaccine plant in Bengaluru, India. According to the paper the firm is in talks with global players seeking manufacturing opportunity for potential Covid-19 vaccine.
And finally, some developments of note in the centring space.
Thermo Fisher has teamed up with China’s Innoforce to establish a biologics and sterile drug manufacturing facility in the country. The facility, in Hangzhou, is due to be operation in 2022.